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SpermCryoProtec

EUDAMEDFDA UDIFDA 510(k)

Class III (EU MDR)

Ref SCP-020

by Nidacon International AB

Identity

Trade Name
SpermCryoProtec EUDAMED
Nidacon FDA UDI
Generic Name
Spermatozoa/semen motility medium supplement FDA UDI
Device Name
SpermCryoProtec EUDAMED
The product is intended to be used as a cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology). FDA UDI
Model / Reference
SCP-020 EUDAMED
Sperm CryoProtec™ FDA UDI
Description
The product is intended to be used as a cryopreservative for protecting human sperm during cryopreservation, an adjunct to one of the techniques for ART (assisted reproductive technology). FDA UDI

Identifiers

Catalog Number
SCP-020 FDA UDI
Primary DI / UDI-DI
07350025610153 EUDAMEDFDA UDI
Basic UDI-DI
B-07350025610153 EUDAMED
510(k) Number
K023206 FDA UDI
FDA Product Code
MQL FDA UDI
EMDN Code
U08020502 MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION EUDAMED
GMDN Term
Spermatozoa/semen motility medium supplement FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
884.6180 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

SpermCryoProtec by Nidacon International Ab — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Nidacon International AB
EUDAMED SRN
SE-MF-000001933

Sources (3)

  • EUDAMED 3b34b867-56f9-492f-b53a-7dbe2da2dfdc 61 fields · synced Jul 14, 2026
  • FDA UDI a22a65d1-26a8-4a71-8d2a-17d79c598b32 37 fields · synced May 30, 2026
  • FDA 510(k) K023206 1 fields · synced May 18, 2026